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OpenTrials
Completed

NCT Number: NCT01531036

3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

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Key information

Conditions

Malignant Breast Tumours

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Curie Cancer Institute

Paris, 75005, France

About this study

3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients having already undergone a breast MRI
  • Patients presenting with breast lesions measuring between20-50mm in ultrasound

Exclusion criteria

  • Multifocal lesions
  • History of breast cancer
  • Breast implants
  • Inflammatory breast disease
  • Pregnancy

Treatment and study plan

3D Ultrasound elastography by means of shear wave propagation into breast tissue

Device

Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography

Other names: Aixplorer Supersonic Imagine

Primary outcomes

  1. 3D volumetric elasticity measurements

    Time frame: 10min

    An utrafast shear wave imaging 3-plane acquisition provides several frames of breast lesion elasticity, that are reconstructed by means of a dedicated software thus permitting the direct volumetric elasticity measurements in kPa

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2012
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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